The present invention is directed to manufacturing systems in general, and more specifically, to a flexible manufacturing platform, which includes single-use or disposable, flexible modules.
With bio/chemical/pharmaceutical manufacturing, the speed for producing drugs for clinical trials and the speed to market are important factors. Clinical milestones impact the value of the drug pipeline, stock values, financing, partnering and licensing opportunities. In addition, the high cost of drug development has been a topic of increasing interest within the industry and appears as part of the public concern regarding rising health care costs.
Much of the expense of biopharmaceutical manufacturing can be attributed to the capital investment required to build manufacturing infrastructure for producing a particular drug. Ideally, having manufacturing capacity immediately available to support every clinical and commercial need would greatly speed development of drugs. However, the capital investment required to build such bio-manufacturing capacity is too great, especially since facilities would sit idle while waiting for the drug in the development pipeline. Because development timelines, dosages, market size, clinical success, and regulatory approval are all uncertainties, the dilemma is compounded by the difficulty in accurately predicting production capacity requirements.
Due to the foregoing uncertainties and the high probability that an individual drug will fail during clinical trials, any investment in facilities for manufacturing drugs prior to successful clinical trials and/or regulatory approval is a high risk endeavor.
To reduce such expenses, an ideal manufacturing facility would be one that is inexpensive to build, can be rapidly expanded and reconfigured to handle new processes and produce drugs quickly. Moreover, it would be advantageous for such a manufacturing facility to be able to maintain and improve upon the high level of quality required for current good manufacturing practice (cGMP) for drug manufacture e.g., conformance with 21 C.F.R. Part 11).
Other manufacturing expenses may be attributable to, for example, the extensive use of non-disposable components. Such components are relatively expensive, and must be cleaned after every use. For example, stainless steel vessels are used extensively in drug manufacturing processes. Such vessels must be connected by stainless steel piping to other unit operations, media and buffer supply, water and clean-in-place and steam-in-place systems. The fabrication and installation of these vessels, and all the utilities that support them, is expensive and requires considerable lead time to design and manufacture.
Even assuming that a manufacturing facility can be built, the resulting facility is often difficult to reconfigure for new processes, or is prohibitively expensive to build in a configuration suitable for manufacturing multiple products simultaneously. Such a manufacturing scheme must be replicated in several parallel clean room environments, separated by airlocks, accessed through clean corridors, and served by dedicated HVAC units.